SPYSCOPE ACCESS AND DELIVERY CATHETER

Additional Manufacturer Narrative

ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative

A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE PEBAX WAS CUT NEAR THE TIP. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE SHEATH WAS TORN NEAR THE TIP. THE EVALUATION ATTRIBUTED THIS FAILURE TO THE MANUFACTURING PROCESS. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS SUPPLIER MANUFACTURE. AN INVESTIGATION IS UNDERWAY TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. (B)(4).

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01371 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE SPYSCOPE SPLIT LENGTHWISE, BUT REMAINED IN ONE PIECE. ADDITIONALLY, THE SPYGLASS PROBE WHICH WAS WITHIN THE SPYSCOPE BROKE INTO TWO PIECES. NO PART OF THE SPYGLASS PROBE DETACHED INTO THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

Description of Event or Problem

NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01371 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE SPYSCOPE SPLIT LENGTHWISE, BUT REMAINED IN ONE PIECE. ADDITIONALLY, THE SPYGLASS PROBE WHICH WAS WITHIN THE SPYSCOPE BROKE INTO TWO PIECES. NO PART OF THE SPYGLASS PROBE DETACHED INTO THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER SPYSCOPE ACCESS AND DELIVERY CATHETER AND SPYGLASS DIRECT VISUALIZATION PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.